Yo u r G e r ma n s o u rc e f o r o n c o lo gy p r o d u c ts

Jürgen Lehmberg, Commercial Director

Dr. Stephan Zinzen, Head of R&D

“You need a flexible supply, sometimes even for small quantities?”

“You are looking for a German supplier for the most important

oncology products?”

Nadine Schröder, Head of Regulatory Affairs

AqVida is a German pharmaceutical company ba-sed in Hamburg with manufacturing facilities in Dassow, Germany. We are specialized in oncology products and our team of experts offer:

• Generic Product Development

• High-End Production

• Efficient Registration Support

• Licensing of Dossiers and MAs

• Flexible and Competitive Supply

Our aim is to produce the world’s best oncology products and make them available to patients or healthcare professionals around the world at re-asonable and affordable prices.

Our products are registered in several EU coun-tries and through our licensing partners we be-came an important supplier for oncology pro-ducts to the German market.

AQVIDA - YOUR GERMAN SOURCE FOR ONCOLOGY PRODUCTS

“You need quick market access and strong

regulatory support?”

AqVida is dedicated to 100% German quality standards. This includes all processes, products and services for every client around the world. Our in-house laboratory provides the entire infra-structure, enabling our qualified team to conductanalytics and quality control according to our strict quality management processes.

GMP-certified processesAqVida‘s quality management system conformsto all German and EU legal requirements for thepharmaceutical industry, including AMG, AMWHVand EU-GMP – regularly certified by the GermanHealth Authorities. We continuously improve standards, procedures and collectively exercise AqVida‘s „Quality is Key“ philosophy. This princi-ple is maximizing product and health safety and is reflected in an uncompromising SOP system. Quality assurance accompanies the complete product cycle.

AQVIDA LABORATORY - QUALITY IS KEY

Bernd Temme, Head of QC and QA

“You expect your supplier to carry out regular audits of the complete

supply chain to secure an outstanding quality of the products?“

In-house capabilities include:

• HPLC

• GC

• IR

• UV

• Water Content

• Gel-Electrophoresis

• IEF

• Western Blot

• Titration

• Sterility

• Microbiological Analytics

• Uncompromising SOP system

• Stringent Quality Standards

• Regulatory Affairs involvement through product life cycle

ensures maximum quality of dossiers and documentation

• Regular audits and inspections of all suppliers

EU-GMP AND BEYOND. STRIVING FOR PERFECTION.

Pilot and production

autoclaves & freeze dryers

Full GMP compliance

21 CFR Part 11 conform

Customized solutions

Reliable and safe results

Zirbus technology gmbhHilfe Gottes 137539 Bad Grund / Harz

Telefon: +49(0)5327 83 80 – 0Fax: +49(0)5327 83 80 – 80E-Mail: info@zirbus.deInternet: www.zirbus.de

Since 1984 experience as a manufacturer of autoclaves and lyophilization systems for pharmaceutical industry.

Made in Germany.

German enGineerinG under hiGh pressure

AQVIDA ROBOTIC FILLING LINE – PRODUCING QUALITY IN ONCOLOGY INJECTABLES

Here at AqVida, innovation is part of our DNA. To improve product quality and production safety and to save cost and time, we envisioned a filling machine without format parts. By combining ro-botic arms and sensor technology, we conceptu-alized a new filling system to considerably mini-mize rejected vials during production. With the help of Steriline, we were able to create this new filling line, based on these concepts.

Fast robotic arms have been implemented in semi-conductor industry for decades, providing a highly reliable service in a very stringent cle-an room requirement. But there had never been a breakthrough in pharmaceutical industry for

robotic arms. Now AqVida is at the forefront of that breakthrough, and this new achievement was presented at ISPE conferences.

The new filling machine is installed inside isola-tors, so that the personal safety and the product quality are both ensured at highest level. The new machine is tailored to AqVida’s process for onco-logy and sterile parenteral filling, offering maxi-mum flexibility and efficiency. Due to zero loss during filling process and flexible batch sizes, AqVida filling line is suitable for commercial bat-ches as well as for very targeted oncology medici-nes, development projects and clinical trials.

Dwight You, Head of Production“You believe that technological

advance should improve the safety of products?”

AQVIDA ROBOTIC FILLING LINE –INNOVATIVE, FLEXIBLE AND EFFICIENT

• „Zero“ format parts

• „Zero“ loss of product liquid

• filling of cytotoxic molecules and antibody drug conjugates (ADCs)

• Filling range : 1 ml – 100 ml vials

• Bulk batch size: 10 liters – 300 liters

AqVida, together with the partner Remoin, an Italian spe-cialist in compounding systems and WFI systems, built an ultra modern compounding system that is tailored to AqVida‘s production process.

The system consists of mobile compounding tanks and isolator with a special split valve system, which provides a closed system for compounding operation. This system prevents contamination to the product liquid, while mi-nimizing the exposure of operators to the cytotoxic APIs.

Joachim Bär, Head of Engineering Department

THE AQVIDA COMPOUNDING SYSTEM

“You think that only a strong technical backbone can

guarantee a steady and safe production?”

THE AQVIDA COMPOUNDING SYSTEM

• Compounding system with isolator technology

• Cytotoxic APIs are transferred to tanks via special

split valve to increase the quality of the product

and safety for operators

• Automated CIP and SIP cycles provide validated processes

• Mobile tanks give flexibilities to batch sizes and production operations Tanks can be added and dedicated for certain products

Innovate Improve Grow

For 40 years MRC have set standards, and driven innovation,

world’s most advanced modular cleanroom panel system MRC

enquiries@mrc-cleanrooms.com

+971 4 883 5908

www.mrc-cleanrooms.com

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AQVIDA – A GLOBAL COMMITMENTHIGH QUALITY ONCOLOGY TREATMENT FOR THE WORLD

AqVida is the reliable German source for oncology products – for partners, pharmacists, doctors and pa-tients. However, a high quality product is only the first step to a high quality treatment. That is why we:

Our task is only completed if all cancer patients have access to high quality products and treatments at affordable and reasonable prices.

• Organize congresses and speeches

• Sponsor visits to congresses for international know-how exchange

• Support training programs for international healthcare specialists

• Carry out post marketing studies

• AQVIDA INNOVATION - AqVida is developing

a mobile container for sterile compounding to

establish German hygiene standards all over

the world

Wolfgang Heinze, CEO

“Did some of my colleagues guess what you are looking for?

If yes I have good news: You have found your partner in oncology!”

“Welcome to the Pharma-tastic world of AqVida!"

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AqVida GmbH

HeadquartersKaiser-Wilhelm-Str. 89 · 20355 Hamburg · Germany

Manufacturing SiteWerkstr. 21 · 23942 Dassow · Germany

Phone: +49 (0) 40 380 371 90info@aqvida.com www.aqvida.com

Yo u r G e r ma n s o u rc e f o r o n c o lo gy p r o d u c ts